Recall readiness
Lot traceability, retained samples, and mock recalls.
HBM maintains recall readiness through full lot traceability, retained samples, and periodic mock-recall exercises, part of cGMP under 21 CFR Part 111. Any batch can be traced, located, and reconciled quickly if a brand ever needs to act.
Lot traceability
Every finished lot ties back through batch records to its raw-material lots, in-process checks, and distribution. That chain lets a specific batch be identified and located fast, the foundation of any effective recall.
Mock recalls and retained samples
HBM runs periodic mock-recall exercises to test that the trace-and-reconcile process works, and keeps retained samples of production lots for reference and testing. Readiness is verified, not assumed.
| Traceability | Finished lot to raw-material lot |
|---|---|
| Testing | Periodic mock recalls |
| Samples | Retained per lot |
| Standard | 21 CFR Part 111 (cGMP) |
FAQ
Does HBM run mock recalls?
Yes. Periodic mock-recall exercises verify the trace-and-reconcile process works.
Can HBM trace a specific lot?
Yes. Lot traceability ties finished product back through batch records to raw-material lots.
Are retained samples kept?
Yes, production lots are retained for reference and testing.
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